Tag: Regulatory Expectations & Inspection Readiness

Common Regulatory Pitfalls in CPV Implementation

Common Regulatory Pitfalls in CPV Implementation Common Regulatory Pitfalls in CPV Implementation Continued Process Verification (CPV) is imperative for maintaining process equipment in compliance with regulatory requirements and quality standards. As pharmaceutical manufacturing shifts toward more robust process validation practices,…

Case Study: Successful CPV Audit Outcome

Case Study: Successful CPV Audit Outcome Case Study: Successful CPV Audit Outcome In the highly regulated pharmaceutical industry, ensuring the integrity and reliability of the manufacturing process is paramount. Continued Process Verification (CPV) plays a vital role in this regard,…

CPV Observations in FDA 483s and Warning Letters

CPV Observations in FDA 483s and Warning Letters Continued Process Verification (CPV) has become increasingly critical in ensuring the ongoing quality and compliance of pharmaceutical manufacturing processes. The CPV framework emphasizes continuous assessment and validation of manufacturing processes based on…

Preparing CPV Documentation for Regulatory Inspections

Preparing CPV Documentation for Regulatory Inspections Preparing CPV Documentation for Regulatory Inspections Continued Process Verification (CPV) is a crucial element in the lifecycle management of pharmaceutical manufacturing processes. It aims to ensure that processes remain in a state of control…

EMA and WHO Expectations for CPV Data Review

EMA and WHO Expectations for CPV Data Review EMA and WHO Expectations for CPV Data Review In the evolving landscape of pharmaceutical manufacturing, the regulatory framework guiding validation practices necessitates a robust understanding of the lifecycle approach to process validation.…

FDA Guidance on Continued Process Verification (CPV)

FDA Guidance on Continued Process Verification (CPV) In-Depth Guide: FDA Guidance on Continued Process Verification (CPV) Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The foundation of any validation lifecycle begins with the development of a User Requirements…